GTBP GT Biopharma Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

 

Date of Report:

(Date of earliest event reported)

 

January 27, 2025

 

GT Biopharma, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other Jurisdiction

of Incorporation)

 

1-40023 (Commission File Number)

94-1620407 (IRS Employer Identification No.)

 

315 Montgomery Street, 10th Floor

San Francisco, CA 94104

 

(Address of Principal Executive Offices and zip code)

 

(415) 919 4040

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12(b))
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each Class		Trading Symbol(s)		Name of each Exchange on which registered
Common stock, $0.001 par value		GTBP		The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 8.01.

Other Events.

 

First Patient Dosed in Phase 1 Trial of GTB-3650

 

On January 27, 2025, GT Biopharma, Inc. (the “Company”) issued a press release announcing that the first patient was dosed in the Phase 1 Trial of GTB-3650, Second-Generation TriKE for the Treatment of Hematologic Malignancies.

 

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Corporate Presentation

 

Our updated corporate presentation as of January 27, 2025, which has been posted to our website, is filed as Exhibit 99.2 and is incorporated herein by reference.

 

Item 9.01.

Financial Statements and Exhibits

 

(d)

Exhibits.

 

Exhibit Number		Description
99.1		Press Release issued January 27, 2025, entitled “GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-3650, Second-Generation TriKE for the Treatment of Hematologic Malignancies”.
99.2		GT Biopharma, Inc. Corporate Presentation as of January 27, 2025
104		Cover Page Interactive Data File (embedded as Inline XBRL document).

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	GT BIOPHARMA, INC.
Date: January 27, 2025	By:	/s/ Alan Urban
		Alan Urban
		Chief Financial Officer

 

 

 

Exhibit 99.1

 

 

GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-3650, Second-Generation TriKE for the Treatment of Hematologic Malignancies

 

●

Initial data from the Phase 1 trial expected in 2025

 

SAN FRANCISCO, CALIFORNIA, January 27, 2025 /Globe newswire/ — GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE^® platform, today announced that the first patient was dosed in a Phase 1 trial evaluating GTB-3650, its second-generation TriKE, for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.

 

“We are thrilled to initiate patient dosing with GTB-3650 in the Phase 1 trial to evaluate the potential in patients with hematological malignancies, which represents a significant milestone for the company. As we continue to progress through clinical development, we eagerly anticipate sharing initial data from the study in 2025”, said Michael Breen, Executive Chairman and interim Chief Executive Officer of GT Biopharma.

 

GTB-3650 is GT Biopharma’s wholly owned second-generation TriKE. It utilizes camelid nanobody technology, with the potential to improve potency and enhance binding affinity. The Phase 1 dose escalation study will evaluate GTB-3650 in up to approximately 14 patients (seven cohorts) with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity. More details can be found on clinicaltrials.gov with the identifier: NCT06594445.

 

About GT Biopharma, Inc.

 

GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. For more information, please visit gtbiopharma.com.

 

 

Forward-Looking Statements

 

Certain statements in this press release may constitute “forward-looking statements” regarding future events and our future results. All statements other than statements of historical facts are statements that could be deemed to be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as “expects,” “anticipates,” “targets,” “goals,” “projects”, “intends,” “plans,” “believes,” “seeks,” “estimates,” “endeavors,” “strives,” “may,” or variations of such words, and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements are subject to a number of risks, uncertainties and assumptions that are difficult to predict, estimate or verify. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Such risks and uncertainties include those factors described in our most recent annual report on Form 10-K, as such may be amended or supplemented by subsequent quarterly reports on Form 10-Q, or other reports filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made only as of the date hereof, and we undertake no obligation to publicly release the result of any revisions to these forward-looking statements. For more information, please refer to our filings with the Securities and Exchange Commission.

 

TriKE® is a registered trademark owned by GT Biopharma, Inc.

 

Investor Relations Contact:

 

LifeSci Advisors

Corey Davis, Ph.D.

cdavis@lifesciadvisors.com

212-915-2577

 

 

 

Exhibit 99.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

v3.24.4

Cover	Jan. 27, 2025
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Jan. 27, 2025
Entity File Number	1-40023
Entity Registrant Name	GT Biopharma, Inc.
Entity Central Index Key	0000109657
Entity Tax Identification Number	94-1620407
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	315 Montgomery Street
Entity Address, Address Line Two	10th Floor
Entity Address, City or Town	San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94104
City Area Code	(415)
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Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, $0.001 par value
Trading Symbol	GTBP
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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